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A pilot protocol of a calcineurin-inhibitor free regimen for kidney transplant recipients of marginal donor kidneys or with delayed graft function.

机译:无钙调神经磷酸酶抑制剂治疗方案的试验方案,适用于边缘供体肾脏或移植功能延迟的肾脏移植接受者。

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The worsening shortage of cadaver donor kidneys has prompted use of expanded or marginal donor kidneys (MDK), i.e. older age or donor history of hypertension or diabetes. MDK may be especially susceptible to calcineurin-inhibitor (CI) mediated vasoconstriction and nephrotoxicity. Similarly, early use of CI in patients with delayed graft function may prolong ischaemic injury. We developed a CI-free protocol of antibody induction, sirolimus, mycophenolate mofetil, and prednisone in recipients with MDK or DGF. METHODS: Adult renal transplant recipients who received MDK or had DGF were treated with a CI-free protocol consisting of antibody induction (basiliximab or thymoglobulin), sirolimus, mycophenolate mofetil, and prednisone. Serial biopsies were performed for persistent DGF. Patients were followed prospectively with the primary endpoints being patient and graft survival, biopsy-proven acute rejection, and sirolimus-related toxicity. RESULTS: Nineteen recipients were treated. Mean follow-up was 294 days. Actuarial 6- and 12-month patient survival was 100% and 100% and graft survival was 93% and 93%, respectively. The only graft loss was due to primary non-function (PNF). The incidence of AR was 16%. Mean serum creatinine at last follow-up was 1.6 mg/dL. Sirolimus-related toxicity included lymphocele (1), wound infection (2), thrombocytopenia (1) and interstitial pneumonitis (1). CONCLUSION: A CI-free protocol with antibody induction and sirolimus results in low rates of AR and PNF and excellent early patient and graft survival in patients with MDK and DGF. CI-free protocols may allow expansion of the kidney donor pool by encouraging utilization of MDK at high risk for DGF or CI-mediated nephrotoxicity.
机译:尸体供体肾脏的日益恶化,促使人们使用扩大的或边缘的供体肾脏(MDK),即年龄较大或高血压或糖尿病的供体病史。 MDK可能特别容易受到钙调神经磷酸酶抑制剂(CI)介导的血管收缩和肾毒性的影响。同样,在移植物功能延迟的患者中早期使用CI可能会延长缺血性损伤。我们开发了一种不含CI的方案,用于MDK或DGF受体的抗体诱导,西罗莫司,霉酚酸酯和泼尼松。方法:接受MDK或DGF治疗的成年肾移植受者接受无CI方案治疗,包括抗体诱导(贝司西单抗或胸腺球蛋白),西罗莫司,霉酚酸酯和强的松。进行了连续DGF的活检。对患者进行前瞻性随访,主要终点是患者和移植物存活,活检证实的急性排斥反应以及西罗莫司相关的毒性。结果:治疗19名接受者。平均随访294天。精算6个月和12个月患者生存率分别为100%和100%,移植物生存率分别为93%和93%。唯一的移植损失是由于原发性无功能(PNF)引起的。 AR的发生率为16%。最后一次随访时的平均血清肌酐为1.6 mg / dL。西罗莫司相关的毒性包括淋巴膨出(1),伤口感染(2),血小板减少(1)和间质性肺炎(1)。结论:无CI方案的抗体诱导和西罗莫司治疗可降低AR和PNF的发生率,并能使MDK和DGF患者的早期患者和移植物存活率更高。不含CI的方案可通过鼓励使用DGF或CI介导的肾毒性高风险的MDK来扩大肾脏供体库。

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